Manager Validation

<h1></h1><h1><b>Job Summary</b></h1><p></p>Oversees the development and improvement of chemical and biological manufacturing processes for drugs and biological materials, while addressing issues related to the production scale-up and ensuring compliance with formulation specifications.<br><br>Salary Range: $90,816-$126,991<br><br>Position is eligible to participate in a bonus plan with a target of 10% of the base salary.<br><br>Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.<br><br>Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.<h1></h1><p style="text-align:inherit"></p><h1><b>Responsibilities</b></h1><h1></h1><ul><li>The Manager/Team Leader oversees the following accountabilities in the assigned unit / department or team:</li><li>Developing new and improved processes for the economical, efficient, and safe chemical/biological manufacture of experimental and bulk active-drug/biological materials</li><li>Preparing large quantities of experimental drug/biological materials for extended analytical, pharmaceutical, biological, and clinical investigations</li><li>Reviewing and resolving issues involving the physical properties of a bulk product to ensure acceptability as required by formulation specifications</li><li>Making recommendations concerning acquisition and use of new technological equipment and materials</li><li>Manages the operational startup of major equipment and or processes by coordinating with Engineering, Operations, and Quality Control/Assurance Management.</li><li>Manages the preparation and approval of validation protocols for critical equipment.</li><li> Reviews final documentation packages for all major validated systems at the plant including, but not limited to utility systems, filling operations, packaging operations, dry heat sterilization/ depyrogenation, steam sterilizers and process washers.</li><li>    Manages documentation required for regulatory submissions or responses as required, and assigns support for collection of information as needed.</li><li>    Manages Coordination of qualification and re-qualification of manufacturing equipment.  Review and approval of Protocols (Installation Qualification, Operational Qualification, Performance Qualifications) and final reports.</li><li>    Responsible for preparation and updating of Validation Master Plan for Aseptic and Terminal Sterilization operation.</li><li>    Manages project requirements with outside customers and vendors as required.</li><li>    Responsible for evaluating/ troubleshooting equipment malfunctions and modifications as related to the Validation, and assigning change control requirements, where applicable.</li><li>    Successful accomplishment of requalifications / periodic reviews of equipment according to site policies.</li><li>    Successful validation (IQ, OQ, PQ) of all new equipment required to support plant operations.</li></ul><p></p><p><b><u>REQUIREMENTS</u></b></p><ul><li>Minimum 4-year degree in a Science or Engineering field of study or combination of education, experience, and training.</li><li>5 &#43; years of related experience in a cGMP facility</li></ul><ul><li>Installation, Operational and Performance Qualification protocol generation and execution</li></ul><ul><li>PC literate with standard office application (Word, Excel, PowerPoint, Project, Access) competency</li></ul><ul><li>Knowledge and understanding of cGMPs, industry guidance, and aseptic techniques</li></ul><ul><li>Understanding of statistical analysis tools and methods</li><li>Good communication skills and leadership skills are required.</li></ul><h1></h1><p style="text-align:inherit"></p><h1><b><span>Additional Information</span></b></h1><p style="text-align:inherit"></p><p style="text-align:left"><span>We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, <span><span><span><span class="WCO0">disability, 401K</span></span></span></span> with company </span><span>contribution</span><span>, and wellness program. </span></p><p style="text-align:inherit"></p><p style="text-align:left"><span>Fresenius Kabi is an Equal <span><span><span><span class="WCO0">Opportunity/Affirmative</span></span></span></span> Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.</span></p>